Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | — | OT |
administered a booster dose of fluzone np to a 9-month-old earlier than scheduled with no reported adverse event; Initial information received on 26-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 months old female patient who was administered a booster dose of influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] earlier than scheduled with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. . On 29-Jan-2025 patient received an unknown dose 1 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- unknown, expiry date and lot not reported) via unknown route in unknown administration site for Influenza. On 11-Feb-2025, the patient received an unknown booster dose 2 of influenza USP TRIVAL A-B subvirion no preservative vaccine (expiry date- 30-JUN-2025 and lot U8465BA) via unknown route in unknown administration sit for Influenza earlier than scheduled with no reported adverse event (inappropriate schedule of product administration) (latency- same day). Information on the batch number for dose 1 was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.